Establish a Public Private Partnership for COVID19 Research

建立新冠肺炎研究公私合作伙伴关系

• 批准号: 10893077
• 负责人: Stacey Adam
• 金额: $ 59.87万
• 依托单位: FOUNDATION FOR THE NIH
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-02 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10893077
• 关键词: Acceleration; Acute; Agreement; Alzheimer' s Disease; Area; Authorization documentation; Businesses; COVID-19; COVID-19 mortality; COVID-19 pandemic; COVID-19 therapeutics; Collaborations; Congresses; Contracts; Disease; Disease Pathway; Familiarity; Foundations; Funding; Funding Agency; Future; Goals; Grant; Health financing; Industry; Lupus; Mediation; Medicine; Mental Health; Mission; Non-Insulin-Dependent Diabetes Mellitus; Nonprofit Organizations; Paper; Parkinson Disease; Persons; Phase; Policies; Private Sector; Privatization; Public Health; Research; Research Personnel; Resources; Rheumatoid Arthritis; Schizophrenia; Science; Secure; Speed; Structure; Subgroup; Therapeutic Intervention; Time; Training; United States; United States Food and Drug Administration; United States National Institutes of Health; Universities; Vaccines; Work; authority; biopharmaceutical industry; cost; design; experience; improved; programs; public-private partnership; response; therapeutic development; therapeutic vaccine

The Foundation for the National Institutes of Health (FNIH) (www.fnih.org) was chartered by the Congress of the United States in 1990 as a not-for-profit 501(c)(3) charitable organization and has been working to facilitate groundbreaking research at the National Institutes of Health (NIH) and worldwide since 1996, creating and managing numerous biomedical public-private research partnerships that support the NIH’s mission. The FNIH therefore has extensive experience working with both NIH and the biopharmaceutical industry and deep familiarity with NIH’s people, science, practices, and policies. The FNIH has been asked by Dr. Francis S. Collins, Director of the NIH, to assist the agency in its response to the COVID-19 crisis. The aim of this collaboration is to accelerate NIH research urgently required to respond to this public health threat and to save lives by leveraging private-sector scientific expertise, in-kind assets and financial resources to augment federal efforts. Dr. Collins’ request that the FNIH help create a COVID-19 public-private partnership (PPP) to accelerate the development of therapeutics and vaccines under the Accelerating Medicines Partnership (AMP) is consistent with the FNIH’s own mission and the Congressional statute by which the FNIH was established to support the NIH in its mission and to advance collaboration with biomedical researchers from universities, industry, nonprofit organizations and other federal agencies, including the US Food and Drug Administration (FDA). AMP is a nimble and powerful public-private partnership that includes the NIH, FNIH, FDA and multiple biopharmaceutical companies and not-for-profit organizations. Managed by the FNIH, AMP programs bring together the resources of the NIH and industry to improve our understanding of disease pathways and facilitate better selection of targets for treatment. Multimillion dollar collaborations supported by the private sector through the FNIH have been established in four major disease areas: Alzheimer's disease, Type 2 diabetes, Rheumatoid Arthritis (RA)/Lupus and Parkinson's disease. The FNIH is also preparing to launch an AMP in Schizophrenia in partnership with the National Institute on Mental Health (NIMH). The overarching goal of the FNIH in this new AMP is to support the NIH in designing and implementing a strategic and coordinated cross-sector approach to end the current COVID-19 pandemic and to manage future such threats. This PPP is now known as ACTIV, the Accelerated COVID-19 Therapeutic Intervention and Vaccine partnership. Notably, most AMP projects start with a Design Phase that takes approximately 9 months to complete in which the FNIH identifies key partners, establishes scientific working and sub-groups, puts in place governance structures, executes contracts and agreements, deploys and trains appropriate staff, and identifies potential sources of funding. The result of the Design Phase is a detailed scientific and business plan for the PPP, which is called the Implementation Plan (sometimes referred to as the White Paper). The resulting Implementation Phase is a multiyear effort in which the PPP, through management by the FNIH, operationalizes the scientific plan and coordinates this work with critical support provided by NIH using its grants and contracts mechanisms. However, given the acute public health threat that has resulted in tens of thousands of COVID-19 deaths, the FNIH responded immediately to NIH’s call to action, redirecting staff from active, fully funded donor-supported programs to begin work on the Design Phase for the proposed PPP even though no financing for the FNIH’s work has yet been secured. In fact, for the past four weeks, the FNIH staff has been working non-stop on ACTIV, including nights and weekends, and has already achieved in record time what under normal circumstances would have taken months. This redeployment of staff is not sustainable, and the resulting costs and lost revenue are imposing an unacceptable burden on the FNIH’s finances. This request for support under NIH’s Other Transaction Authority (OTA) is, in fact, a do-or-die matter for the FNIH. While other funding sources have been explored and fundraising continues, none have or are likely to be forthcoming in a manner that is sufficiently timely to support the FNIH’s efforts. Quite simply, without immediate funding the FNIH will not be able to continue working on ACTIV and hence will be unable to support the NIH and its mission in this devastating COVID-19 health crisis. As requested in the Request for Negotiation to Establish a Public Private Partnership for COVID19 Research submitted by the NIH, the FNIH provides herein information concerning the work the FNIH has and will undertake until July 31, 2020 and the costs to underwrite that work. While much of this activity concerns the Design Phase, given the urgent need to make progress now, several critical implementation activities are anticipated to commence before July 31, 2020. Please note that this request also includes a separate request for support of the Deloitte Consulting, LLC (Deloitte) contract with the FNIH. Deloitte was contacted to expand and support the FNIH capabilities given the speed and volume of work required for ACTIV.

美国国立卫生研究院基金会（www.fnih.org）是由美国国会特许成立的。 美国于1990年成为非营利501（c）（3）慈善组织，并一直致力于促进 自1996年以来，美国国立卫生研究院（NIH）和全球范围内的开创性研究， 管理众多支持NIH使命的生物医学公私研究伙伴关系。FNIH 因此，他在NIH和生物制药行业都有丰富的工作经验， 与NIH的人员，科学，实践和政策。 弗朗西斯S.柯林斯，美国国立卫生研究院主任，以协助该机构在其回应， 2019冠状病毒病危机这项合作的目的是加速NIH的研究，迫切需要应对这一问题。 利用私营部门的科学专门知识、实物资产和财政资源， 增加联邦努力的资源。 博士柯林斯要求FNIH帮助建立COVID-19公私合作伙伴关系（PPP），以加快 在加速药物伙伴关系（AMP）下开发治疗药物和疫苗符合 FNIH自己的使命和国会法规，FNIH成立的目的是支持NIH， 它的使命，并促进与来自大学，工业，非营利组织， 组织和其他联邦机构，包括美国食品和药物管理局（FDA）。 AMP是一个灵活而强大的公私合作伙伴关系，包括NIH，FNIH，FDA和多个 生物制药公司和非营利组织。由FNIH管理，AMP计划带来了 整合NIH和行业的资源，以提高我们对疾病途径的理解， 更好地选择治疗目标。私营部门支持的数百万美元的合作， FNIH已经在四个主要疾病领域建立：阿尔茨海默病、2型糖尿病、风湿病 关节炎（RA）/狼疮和帕金森病。FNIH还准备在2010年在精神分裂症中推出AMP 国家心理健康研究所（NIMH）。 在这个新的AMP中，FNIH的总体目标是支持NIH设计和实施一个战略性的 以及跨部门的协调方法，以结束当前的COVID-19疫情并管理未来的此类威胁。 这个PPP现在被称为ACTIV，即加速COVID-19治疗干预和疫苗伙伴关系。 值得注意的是，大多数AMP项目从设计阶段开始，大约需要9个月才能完成， FNIH确定关键合作伙伴，建立科学工作组和分组，建立治理结构， 执行合同和协议，部署和培训适当的工作人员，并确定潜在的资金来源。 设计阶段的结果是一个详细的科学和商业计划的公私伙伴关系，这是所谓的 实施计划（有时称为白色文件）。由此产生的实施阶段是一个多年期 PPP通过FNIH的管理，实施科学计划并协调 这项工作得到了NIH利用其赠款和合同机制提供的关键支持。 然而，鉴于严重的公共卫生威胁已导致数万人死亡，FNIH 立即响应NIH的行动号召，将工作人员从积极的、全额资助的捐赠者支持的项目中抽调出来 开始拟议的公私伙伴关系的设计阶段的工作，尽管FNIH的工作尚未获得资金 被保护。事实上，在过去的四个星期里，FNIH的工作人员一直在为ACTIV不停地工作，包括 在正常情况下， 个月这种工作人员的重新部署是不可持续的，由此产生的费用和收入损失正在迫使政府采取行动， 给FNIH的财政带来了不可接受的负担。 事实上，NIH的其他交易授权（OTA）下的支持请求是一个生死攸关的问题。 FNIH。虽然已经探索了其他资金来源，筹资工作仍在继续，但没有一个来源，也不可能有任何来源。 以一种及时的方式来支持FNIH的努力。很简单，没有立即 资助FNIH将无法继续从事ACTIV的工作，因此将无法支持NIH， 在这场毁灭性的COVID-19健康危机中履行其使命。 根据为COVID 19研究建立公私合作伙伴关系的谈判请求 由NIH提交，FNIH在此提供有关FNIH已经和将要开展的工作的信息。 承诺到2020年7月31日，并承担这项工作的费用。虽然这些活动大多涉及设计， 鉴于目前迫切需要取得进展，预计将开展若干关键的执行活动， 在2020年7月31日之前开始。 请注意，此请求还包括对德勤咨询有限责任公司（德勤）的单独支持请求。 与FNIH签订合同。德勤联系，以扩大和支持FNIH的能力，因为速度和 ACTIV所需的工作量。